Status:
COMPLETED
Lifestyle Intervention Targetting Obesity and Insulin Resistance in Chronic Hepatitis C
Lead Sponsor:
University Health Network, Toronto
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Chronic hepatitis C (CHC) infection affects approximately 1 in 100 Canadians. Untreated, CHC has significant long-term consequences including cirrhosis, liver cancer and liver failure. CHC is intrinsi...
Detailed Description
The hepatitis C virus (HCV) chronically infects an estimated 240,000 in Canada and 170 million worldwide. Untreated, CHC is associated with significant long-term clinical consequences including cirrho...
Eligibility Criteria
Inclusion
- obese (BMI \>/= 30)
- insulin resistant (HOMA-IR \>/= 2.1)
Exclusion
- Genotype 3 patients
- Women with ongoing pregnancy or who are breast-feeding
- Patients with any other other underlying liver disease (viral, alcoholic, druginduced, autoimmune, metabolic, genetic).
- Patients currently on antiviral therapy, or who have ceased therapy within 6 months of recruitment to the study.
- Patients with other causes for insulin resistance e.g., excess counter-regulatory hormones: glucocorticoids, catecholamines, growth hormone, polycystic ovary syndrome).
- Patients on steroids or other drug that affects insulin resistance, which are unable to be stopped for 3 days prior to IR testing.
- Patients with overt diabetes (based on results of fasting plasma glucose) will be excluded from participation as we are focusing on insulin resistance in the absence of diabetes.
- Conditions which preclude a sudden increase in physical activity:
- History or other evidence of chronic pulmonary disease associated with functional limitation.
- History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
- Unable to 10000 steps/day eg physical disability, morbid obesity.
- Evidence of ongoing substance use (including alcohol consumption \>20g/day for men and \>10g/day for women) within one year of study recruitment.
- Poor veins (inadequate venous access)
- Inability or unwillingness to provide informed consent or abide by study requirements eg severe psychiatric illness, lives remotely, time commitment.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00755742
Start Date
November 1 2008
End Date
August 1 2011
Last Update
September 22 2011
Active Locations (1)
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1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T2S8